(49 days)
Not Found
Not Found
I'm sorry, but without further information from the provided text, I cannot answer your question. The document is a 510(k) clearance letter from the FDA for a device called "Autostat™ II Anti-Scl-70 ELISA." This letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
However, the letter does not contain any information regarding:
- Acceptance criteria or reported device performance for a study.
- Details of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Any mention of AI, multi-reader multi-case studies, or standalone algorithm performance.
To provide the information you requested, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a marketing submission that details the performance data of the device.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).